Title of Guideline (must include the word Guideline not protocol, policy, procedure etc)

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1 Title of Guideline (must include the word Guideline not protocol, policy, procedure etc) Author: Contact Name and Job Title Directorate & Speciality Assessment, referral and initial management of ultrasound detected ovarian cysts/masses for NUH gynaecology teams Kate Stewart ST7, David Nunns Consultant Gynaecological Oncologist, NUH Family Health Date of submission Amendments Explicit definition of patient group to which it applies (e.g. inclusion and Women seen in gynaecology clinics or emergency exclusion criteria, diagnosis) admissions areas Version 8 If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-6) 1 NICE Guidance, Royal College Guideline, SIGN (please state which source). 2a 2b 3a 3b meta analysis of randomised controlled trials at least one randomised controlled trial at least one well-designed controlled study without randomisation at least one other type of well-designed quasi-experimental study 4 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 5 expert committee reports or opinions and / or clinical experiences of respected authorities 6 recommended best practise based on the clinical experience of the guideline developer Consultation Process Ratified by:guidelines group NA 1) RCOG (2003), Green-Top Guideline no. 34, Ovarian cysts in post -menopausal women, The Royal College of Obstetricians and Gynaecologists 2) RCOG (2011) Green-Top Guideline no. 62, Management of Suspected Ovarian Masses in Premenopausal women, The Royal College of Obstetricians and Gynaecologists 3) NICE 2011 NICE Clinical Guideline number 122: Ovarian Cancer: the recognition and initial management of ovarian cancer National Institute for Health and Clinical Excellence 4) IOTA 5)Levine D, et al. (2010), Management of asymptomatic ovarian and other adnexal cysts imaged at US: Society of Radiologists in Ultrasound Consensus Conference Statement. Radiology, Vol. 256 (3): rl_ver=z &rfr_id=ori%3arid%3acrossref.org&rfr_dat=cr_pu b%3dpubmed& Senior medical, radiology, staff nurses Date:3/1/19 Target audience Review Date: (to be applied by the Integrated Governance Team) A review date of 5 years will be applied by the Trust. Directorates can choose to apply a shorter review date, however this must be managed through Directorate Governance processes. Gynaecology clinical staff 1/1/2021 This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.

2 Aims and purpose To guide the gynaecology team on the assessment, referral and initial management of ultrasound scan detected ovarian cysts/masses. Summary page for the management of ovarian cysts/masses on USS (please see main text for detail) Postmenopausal ovarian cysts /masses Calculate Risk Malignancy Index (RMI) for all patients (see below). If RMI less than 200 and no malignant features on USS for discussion of surgery eg lap BSO and omental biopsy (NB risk of cancer is higher in postmenopausal group so threshold for surgery may be lower than the premenopausal group) Refer to the Gynae cancer MDT with tumour markers (Ca 125/ CEA) if RMI greater than 200 or malignant features seen (See IOTA criteria below) Scan findings Less than 3cm 3-5cm More than 5cm Simple cyst* Dermoid Endometrioma Low risk/likely benign ovarian cyst/mass (IOTA B) eg benign cystadenoma, fibroma High risk ovarian cysts /mass (ie malignant USS appearances) If the cyst is small with no worrying features, this is most likely to be a residual follicle. No further scan is indicated. No immediate action is indicated manage on clinical grounds Refer to the Gynae cancer MDT with tumour markers (Ca 125) and calculate RMI Suggest rescan with CA-125 measurement in four and eight months. If no change demonstrated in these scans, no further imaging indicated unless clinical concern. If surgery not indicated rescan four months. -If smaller or resolved no further follow up required.) -If larger or symptoms suggest surgical review. -If the same size and no symptoms eight months USS (and then annual if the same) Refer to the Gynae cancer MDT with tumour markers (Ca 125) and calculate RMI Surgery or conservative management (Consider MRI if scan is inconclusive or larger than 7cm) If conservative management eg patient not fit or declines surgery follow-up as per 3-5cm (see left) As above Refer to the Gynae cancer MDT with tumour markers (Ca 125) and calculate RMI Premenopausal ovarian cysts /masses Scan findings Less than 5cm 5-7cm More than 7cm Simple cyst* Corpus luteal cyst Haemorrhagic cyst Dermoid Endometrioma** Low risk/likely benign ovarian cyst/mass (IOTA B) eg benign cystadenoma, fibroma High risk ovarian cysts /mass (ie malignant USS appearances ) No follow up required unless there is clinical concern. Findings are likely to be physiological in nature and almost always resolve within 3 menstrual cycles For surgery or medical management. Ultrasound scan surveillance may be appropriate for selected patients. Rescan four months. -If smaller or resolved no further follow up required.) -If larger or symptoms suggest general gynaecological review. -If the same size and no symptoms an annual scan Refer to the Gynae cancer MDT with tumour markers (Ca 125, AFP, HCG and LDH) *see text for definition ** see special scenarios page 7 If surgery not indicated rescan four months. -If smaller or resolved no further follow up required.) -If larger or symptoms suggest surgical review. -If the same size and no symptoms annual scan For surgery or medical management. Ultrasound scan surveillance may be appropriate for selected patients. Rescan four months. -If smaller or resolved no further follow up required.) -If larger or symptoms suggest general gynaecological review. -If the same size and no symptoms annual scan Refer to the Gynae cancer MDT with tumour markers (Ca 125, AFP, HCG and LDH) Surgery or conservative management (Consider MRI if scan is inconclusive or larger than 7cm) If conservative management eg patient not fit or declines surgery follow-up as per 5-7cm (see left) As above Refer to the Gynae cancer MDT with tumour markers (Ca 125, AFP, HCG and LDH)

3 Background Up to 10% of women will have surgery for an ovarian mass. In premenopausal women almost all ovarian masses and cysts are benign and many patients can be managed conservatively. The underlying management rationale is to minimise patient morbidity by: conservative management where possible providing necessary reassurance. the use of laparoscopic techniques where appropriate, thus avoiding laparotomy for symptom relief and diagnosis. referral or discussion with the gynaeoncology team where appropriate for high risk patients. It should be noted that almost all pelvic ultrasound scan requests will require a transvaginal scan (TVS). TVS is almost always superior to transabdominal ultrasound (TAS) for examining the pelvic organs. Some women cannot accommodate a vaginal scan probe. It is crucial to review previous imaging as current findings on scan may have been reported previously. The decision making process must correlate the scan findings with the clinical scenario and the tumour markers. A thorough medical history should be taken from the woman, with specific attention to risk factors and symptoms suggestive of ovarian malignancy, and a family history of ovarian, bowel or breast cancer. A full physical examination of the woman is essential and should include body mass index, abdominal examination to detect ascites and characterise any palpable mass, and vaginal examination.

4 1.Tumour markers Tumours markers (such as Ca125) are used as a part of patient triage and risk assessment. They are not diagnostic and lack good sensitivity and specificity (eg raised levels can occur in endometriosis and ovulation) Measure CA125 in all women with suspected ovarian cancer. A CA-125 does not need to be undertaken in all premenopausal women such as when an USS diagnosis of a simple ovarian cyst has been made. In women under age of 40 years with complex masses also consider measuring levels of alpha fetoprotein (AFP), beta human chorionic gonadotrophin (beta-hcg) as well as serum CA125, to identify germ cell tumours. 2. Ultrasound interpretation The following cysts should be treated as simple cysts: Ovarian/para-ovarian cyst, cysts containing daughter cysts, Cysts with one thin septation (<3mm, with no vascularity), Cysts with small calcification in wall. If there is an obvious area of calcification consider whether this may be a dermoid cyst. Cyst criteria apply even if cysts are multiple (cysts completely separate from each other) or bilateral Ovarian cysts that persist or increase in size are unlikely to be functional. Larger is defined as more than 10-20% increase in size International Ovarian Tumour Analysis (IOTA) group ultrasound rules for ovarian masses The IOTA group ultrasound rules for ovarian masses are a simple set of ultrasound findings that classify ovarian masses into benign, malignant or inconclusive masses. These rules apply to masses that are not a classical ovarian mass (eg dermoid cyst), which have pathognomonic imaging features. See this site for more information The Group has published the largest study to date investigating the use of ultrasound in differentiating benign and malignant ovarian masses based on five ultrasound features of malignancy (M-features) and five ultrasound features suggestive of a benign lesion (B-features) (See Table 1) An adnexal mass is classified as malignant if at least one M- feature and no B-features are present and vice versa. Using these

5 rules the reported sensitivity was 95% and specificity 91%. Some scan reports may not contain this level of detail. If unsure please discuss with a senior colleague. Women with an ovarian mass with any of the M-rules ultrasound findings should be discussed with the gynaecological oncological service. Please check the patients Ca -125 when referring. Additional imaing - MRI or CT? At the present time the routine use of CT and MRI for assessment of ovarian masses does not improve the sensitivity or specificity obtained by transvaginal ultrasonography in the detection of ovarian malignancy and should be reserved as second line investigation after discussion with a senior colleague. MRI may be indicated if the mass is large (suggested >7cm) or if there are diagnostic USS uncertainties as MRI can assess the primary ovarian mass. CT is of less value in assessing the primary tumour, but is useful for assessing nodes, omentum, peritoneal tumour and liver metastases. Table 1 IOTA Group ultrasound rules to classify masses as benign (B-rules) or malignant (M-rules) B-rules Unilocular cysts Presence of solid components where the largest solid component <7 mm Presence of acoustic shadowing Smooth multilocular tumour with a largest diameter <100mm No blood flow M-rules Irregular solid mass (solid component 80% of the tumour) Presence of ascites At least 4 papillary structures with a height equal or more than 3mm Irregular multi-locular solid tumour with a maximum diameter > 10cm Strong vascularity

6 3. Postmenopausal ovarian cysts /masses See summary page 1 Risk of malignancy index (RMI) (triage tool for referral and further diagnostic tests) It combines three pre-surgical features: serum CA125 (CA125), menopausal status (M) and ultrasound score (U). The RMI is a product of the ultrasound scan score, the menopausal status and the serum CA125 level (IU/ml). RMI = U x M x CA125 Calculate RMI for all patients (see below). If RMI less than 200 and no malignant features on USS for discussion of surgery eg lap BSO and omentum (NB risk of cancer is higher in postmenopausal group so threshold for surgery may be lower than the premenopausal group) Refer to the Gynae cancer MDT with tumour markers (Ca 125/ CEA) if RMI greater than 200 or malignant features seen (See IOTA criteria above). The pooled sensitivities and specificities of an RMI I score of 200 in the detection of ovarian malignancy are sensitivity 78% (95% CI 71-85%) and specificity 87% (CI 83-91%). The value is less in premenopausal women where Ca-125 levels may be raised with benign conditions eg, endometriosis. RMI score = ultrasound score x menopausal score x CA125 in U/ml. Feature RMI score Ultrasound multilocular cyst 0= none solid areas 1= one abnormality bilateral lesions 3= two or more abnormalities ascites intra-abdominal metastases Premenopausal 1 Post menopausal 3 Ca 125 U/ml 4. Premenopausal cysts/masses follow up See summary page 1 Consider following the International Ovarian Tumour Analysis (IOTA) group ultrasound rules for reporting ovarian masses (see page 5)

7 5. Special scenarios 5.1 Endometriomas This is a benign, localised collection of blood within an ovary (aka Chocolate cyst) that can be diagnosed on USS as they can have characterstic appearances. Symptomatic patients (such as those with pain or infertility) may benefit from specialist review as imaging (i.e. expert ultrasound or MRI) may help diagnose deep endometriosis deposits. 5.2 Emergency management of cysts Any cyst that is causing severe symptoms may warrant emergency surgery eg torsion of the ovary. Ovarian torsion o Ovarian torsion accounts for approximately 1 in 5 of emergency gynaecology admissions. It is frequently described as unilateral ovarian enlargement and oedema on USS and has a strong association with large (>5cm) ovarian cysts. o These cysts become haemorrhagic with venous congestion. o Traditionally, surgery has involved partial or complete oophorectomy or salpingo-oophorectomy. o There is evidence to suggest that the clinical appearances of torted adnexae do not correlate well with the likelihood of residual ovarian function and recovery and there are good outcome data to support conservative management with laparoscopic de-torsion in the majority of cases with little short or long-term associated morbidity even if the ovary appears dark purple or black. o True cysts can be drained at the time to maximise ovarian conservation. 5.3 Management of cysts in pregnancy Asymptomatic adnexal masses are frequently diagnosed in pregnancy, either at the dating scan or at the time of caesarean section. They are mostly ovarian in origin. Although the overall incidence of adnexal masses in pregnancy is approximately 4%, the incidence of complex or simple persistent cysts measuring more than 6 cm is only 0.07%. Three-quarters of these persistent cysts are complex in nature and the majority of complex cysts are either benign teratomas or endometriomas. Ovarian cysts in pregnancy can result in cyst rupture, cyst haemorrhage, torsion (up to 5%), obstructed labour and fetal malpresentation

8 The majority of ovarian cysts in pregnancy are benign and can be managed conservatively. Ovarian cancer is extremely rare in women of childbearing age, the overall reported incidence of ovarian cancer in pregnant women varies from %, If there is a suspicion of malignancy or there is a significant cyst complication, such as torsion, and surgery is planned, this should take place during the second trimester to minimise the risk of miscarriage. 5.4 MRI in pregnancy MRI is considered safe in pregnancy (without contrast) and can be helpful in the assessment of an ovarian mass that is thought to be malignant. Please discuss with a senior colleague. 5.5 Tumour markers in pregnancy CA 125 (epithelial cancer) BHCG (germ cells tumours) AFP (germ cells tumours) Inhibin (granulosa and mucinous) LDH (malignant germ cell tumours) Effect of pregnancy Raised during pregnancy due to decidual cell production. Some researchers have suggested using a cut-off level of 112 U/ml Serum AFP, betahcg and inhibin levels are all raised due to placental synthesis Due to the rarity of this neoplasm, data regarding this association is sparse NB. It is of value to perform tumour markers as a normal result will be reassuring. 5.6 Algorithm for management of ovarian cyst in pregnancy (Ref: TOG article, Spencer et al)

9 Inform women that the majority of ovarian cysts resolve spontaneously. Dermoid cysts that are less than 6cm on rescan can be followed up 3 months postnatally to determine further management. Large simple cysts can be drained by USS guided needle aspiration if very symptomatic and is done by the interventional radiologist after multidisciplinary discussion. This should be done after 14 weeks to minimise disturbance to the corpus luteum. If a complex cyst is causing severe symptoms it can be operated upon after 14 weeks to minimise the risk of fetal loss due to miscarriage, although this risk is very small. In some situations, there may be grounds for performing an elective caesarean section at term in addition to deal with a large, complex ovarian tumour that has persisted during the pregnancy but which has not required earlier operative intervention. References: Ameye L, Timmerman D, Valentin L, Palandini D, Zhang J, Van Holsbeke C, Lissoni A, Savelli L, Veldman J, Testa A, Amant F, Van Huffel S, Bourne T (2012), Clinically oriented three-step strategy for assessment of adnexal pathology, Ultrasound in Obstetrics and Gynaecology 40: pp Breijer M., Peeters J., Opmeer B., Clark T., Verheijen R., Mol B., and Timmermans A. (2010), Capacity of endometrial thickness measurement to diagnose endometrial carcinoma in asymptomatic postmenopausal

10 women: a systematic review and meta-analysis, Ultrasound in Obstetrics and Gynecology, Vol. 40:6, Damigos E, Johns J, Ross J. An update on the diagnosis and management of ovarian torsion. The Obstetrician & Gynaecologist. 2012;14: Europeam Society of Human Reproduction and Embryology (ESHRE) (2013), Management of women with endometriosis: Guideline of the European Society of Human Reproduction and Embryology, European society of human reproduction and embryology Hartman A., Wolfman W., Nayot D., Hartman M., (2013) Endometrial Thickness in 1,500 Asymptomatic Postmenopausal Women Not on Hormone Replacement Therapy; Gynecologic and Obstetric Investigation, Vol. 75: Levine D, Brown DL, Andreotti RF, Benacerraf B, Benson CB, Brewster WR, Coleman B., DePriest P., Doubilet P., Goldstein S., Hamper U., Hecht J., Horrow M., Hur H., Marnach M., Patel M., Platt L., Puscheck E. and Smith-Bindman R. (2010), Management of asymptomatic ovarian and other adnexal cysts imaged at US: Society of Radiologists in Ultrasound Consensus Conference Statement. Radiology, Vol. 256 (3): Kaijser J., Bourne T., Valentin L., Sayasneh A., Van Holsbeke C., Vergote I., Testa A., Franchi D., Van Calster B. and Timmerman D. (2013), Improving strategies for diagnosing ovarian cancer: a summary of International Ovarian Tumor Analysis (IOTA) studies, Ultrasound Obstetrics and Gynecology, Vol. 41:1, 9-20 Kaijser J.(2015) Towards an evidence-based approach for diagnosis and management of adnexal masses: findings of the International Ovarian Tumour Analysis (IOTA) studies, Facts, Views and Vision in OBGYN 7 (1), pp Nunes N, Ambler G, Foo X, Naftalin J, Widschwendter M, Jurkovic D 2014, Use of IOTA simple rules for diagnosis of ovarian cancer: meta - analysis, Ultrasound in Obstetrics and Gynaecology 44, pp NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE) 2011 NICE Clinical Guideline number 122: Ovarian Cancer: the recognition and initial management of ovarian cancer National Institute for Health and Clinical Excellence

11 The Royal College of Obstetricians and Gynaecologists: Green-Top Guideline no. 34, Ovarian cysts in post -menopausal women, The Royal College of Obstetricians and Gynaecologists (2016), The Royal College of Obstetricians and Gynaecologists: Green-Top Guideline no. 62, (2011) Management of Suspected Ovarian Masses in Pre-menopausal women, The Royal College of Obstetricians and Gynaecologists Scottish Intercollegiate Cancer Network (SIGN) Guideline No 75. Epithelial Ovarian Cancer. October ISBN Spencer CP, Robarts PJ. Management of adnexal masses in pregnancy. The Obstetrician & Gynaecologist 2006;8:14 19.